Given the current regulatory framework, manufacturing issues are a major challenge for sponsors of cell and gene therapies. This article shares some key questions and considerations you should ask yourself in order to make the decision whether or not you should use a CDMO.
- The “Outsourcing Master Class”: 10 Modules For Success
- Pharma Process Validation: Initial Conclusions Are Often Deceptive
- FDA, CDMOs, And COVID: How To Talk About 483s
- 6 Best Practices For Biopharma Talent Management In 2023
- 3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully
- Stand Shoulder-To-Shoulder With Your CDMO
- Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
Pharma Process Validation: Initial Conclusions Are Often Deceptive
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.
6 Best Practices For Biopharma Talent Management In 2023
The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.
3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully
Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.
Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
Decentralized CAR-T Manufacturing: Reduce Cost/Complexity, Expand Access
High costs are endemic to CAR T-cell therapy treatments, leading to a large gap in healthcare between those who can afford to pay and those who cannot. However, changes in manufacturing processes — namely decentralizing them — can reduce costs and complexity while also expanding patient access.
Biomarker Testing: A Key Component To Advancing Precision Medicine
Biomarker testing isn’t always the standard of care for many people living with cancer today. Providers and patients need to be better educated about biomarker testing, we need a consistent standard of care across oncology institutions, and we need to advocate for equitable access to biomarker testing.
Biopharma Facility Modular Design & Construction: Key Considerations
In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.
Beyond Nuclear Genetics: Let’s Think Differently About CNS Disease Targets
Nuclear genes with mutations remain the primary focus for selecting biological drug targets, but we have yet to see a drug come to market from a genetically validated target that can arrest or reverse diseases like Parkinson’s. We need to expand our research to explore the essential drivers, genetic or otherwise, that switch our cells from order to disorder or from function to dysfunction.
PHARMA OUTSOURCING WHITE PAPERS
Amorphous Formulations For Insoluble Drugs: Rational Design & Practical Approaches On Formulation Screening & Development
The issues associated with amorphous formulations include solid state stability, chemical stability, reproducibility of API manufacturing, impurity of API, in vitro in vivo performance, process and scale-up.
Rational Design & Development Of Long-Acting Injectable Dosage Forms
The increasing prevalence of chronic disorders, growing demand for self-administration, and the increasing demand for minimally invasive surgeries have fueled the growth of the LAI drug delivery market.
The Development, Scale-Up, And Manufacturing Of Semi-Solid Dosage Forms
Topical products, whether prescription dermatological drugs or over-the-counter lotions, creams, or gels, present unique challenges in terms of development and manufacturing.
Liposomal And Nanoparticle Technology At Pfizer Melbourne
Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
Revitalization Of Older Drug Products Using Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway
Revitalization of older marketed drug products using innovative drug delivery technologies or platforms can provide new marketing exclusivity and new patent protection, and thus offer an effective tool for product life cycle management.
Extend Your Digital Edge: Bringing Production Record Data Online To Drive Intelligent Manufacturing
By definition, when data is offline or only partially digital, it’s disconnected. This white paper explores why using paper and other standalone tools as an “easy” fix to fill gaps created by disconnected systems, missing or unused software functionality, and outmoded processes presents a bigger risk and results in more missed opportunities than many manufacturers realize.